Cleared Traditional

K942376 - COBAS CORE FREE T3 EIA

K942376 is an FDA 510(k) clearance for COBAS CORE FREE T3 EIA, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K942376 · Roche Diagnostic Systems, Inc. · Chemistry device
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Apr 1995
Decision
338d
Days
Class 2
Risk

K942376 is an FDA 510(k) clearance for the COBAS CORE FREE T3 EIA. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 21, 1995 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K942376

510(k) Number K942376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1994
Decision Date April 21, 1995
Days to Decision 338 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
250d slower than avg
Panel avg: 88d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEC Device Classification - Class 2, Special Controls

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CEC Radioimmunoassay, Free Thyroxine

All 77
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